Auxilium Pharmaceuticals Researchers Find Evidence Of Potential Markers For Cardiovascular Disease In Hypogonadal Type 2 Diabetes Patients
MALVERN, Pa., June 24 /PRNewswire-FirstCall/ -- Auxilium Pharmaceuticals, Inc. , a specialty pharmaceutical company, announced that new findings were presented today at ENDO 2006, the 88th Annual Meeting of the Endocrine Society, suggesting that abnormally low testosterone levels may be linked to indicators of cardiovascular disease in Type 2 diabetes patients. In a comparison of Type 2 diabetes patients with and without hypogonadism, defined by total testosterone levels less than 300 ng/dL, researchers found that HDL levels were significantly lower in patients with hypogonadism, and that triglyceride and C-Reactive Protein levels were significantly higher in patients with hypogonadism. Given the known risk these markers have on cardiovascular disease and the apparent prevalence in association with hypogonadism, the findings reported here warrant further investigation into the potential benefit testosterone replacement therapy can have on patients with type 2 diabetes.
"The correlation of significantly lower HDL levels and significantly higher triglyceride levels and higher CRP in hypogonadal patients raises the issue of the potential importance of androgen concentrations in regulating these cardiac risk factors," Marc S. Rendell, M.D., Creighton Diabetes Center. "This data suggest that it is important to assess testosterone levels as an integral part of the evaluation of male diabetes patients and to treat low levels."
The objective of the study was to characterize possible differences in lipid profiles and C-reactive protein levels between hypogonadal (total testosterone < 300 ng/dL) and non hypogonadal participants. To this end, an analysis was undertaken utilizing the screening records of a cohort of stable Type 2 diabetes patients evaluated for potential inclusion into a multi-center trial. Blood samples from 568 subjects were collected and analyzed for total cholesterol (TC), HDL cholesterol (HDL), LDL cholesterol (LDL), triglycerides (TG), and C-reactive protein (CRP). The mean HbA1c for the cohort was 7.2 plus or minus 1.4 percent. 252 subjects (44.4%) were classified as hypogonadal and 316 (55.6%) subjects were classified as non-hypogonadal.
Mean Value Hypogonadal Spearman Parameter (plus or minus SE) vs. Correlation (mg/dl) Hypogonadal Non-Hypogonadal Non-Hypogonadal With Gonadal Status TC 188.2 (3.6) 182.9 (2.5) (P = 0.40) -0.02 (P = 0.72) HDL 45.3 (0.7) 46.9 (0.6) (P = 0.016) 0.14 (P = 0.0007) LDL 97.5 (2.4) 100.8 (2.0) (P = 0.25) 0.10 (P = 0.0319) TG 261.2 (22.7) 182.2 (8.1) (P < 0.0001) -0.28 (P < 0.0001) CRP 3.5 (0.4) 2.7 (0.3) (P = 0.0008) -0.21 (P < 0.0001)
Data were presented today in a poster titled, "Potential Markers of Cardiovascular Disease in Hypogonadal Type 2 Diabetic Patients" at the ENDO 2006 Annual Meeting in Boston, MA. The study was sponsored by Auxilium Pharmaceuticals, Inc.
Testosterone is an androgen hormone that is primarily responsible for normal growth and development of male sex organs. The normal range for total testosterone in men is generally 300 to 1,000 nanograms per deciliter (ng/dL), depending on the lab performing the test and the methodology used.
A decrease in testosterone production, when testosterone levels drop below the normal range, is sometimes referred to as Low T and is known medically as hypogonadism. A simple blood test conducted by a physician can determine if a man has low testosterone.
Researchers are accumulating clinical evidence that links low testosterone levels to long-term medical conditions such as metabolic syndrome, Type 2 diabetes, coronary heart disease, osteoporosis and depression. Additionally, studies have shown that men who suffer from obesity, diabetes or hypertension may be twice as likely to have low testosterone levels. Several published studies have shown the beneficial effects on men's health by normalizing testosterone levels with testosterone replacement therapy.
About Auxilium Pharmaceuticals
Auxilium Pharmaceuticals, Inc. is a specialty pharmaceutical company with a focus on developing and marketing products for urology, sexual health and other indications within specialty markets. Auxilium markets Testim(R) 1%, a topical testosterone gel, for the treatment of hypogonadism through its approximately 130-person sales and marketing team. Auxilium has five projects in clinical development. Auxilium believes that AA4500, an injectable enzyme, has completed Phase II of development for the treatment of Dupuytren's Disease and is in Phase II of development for the treatment of Peyronie's Disease and Frozen Shoulder Syndrome (Adhesive Capsulitis). Auxilium's testosterone replacement transmucosal film product candidate for the treatment of hypogonadism (AA2600) has commenced Phase III of development and should commence pivotal Phase III trials later this month. Auxilium's transmucosal film product candidate for the treatment of overactive bladder (AA4010) is in Phase I of development. Auxilium has two pain products using its transmucosal film delivery system in pre-clinical development. Auxilium has rights to six additional pain products and products for hormone replacement and urologic disease using its transmucosal film delivery system, options to all indications using AA4500 for non-topical formulations, and other products for urology and sexual health. For additional information, visit http://www.auxilium.com.
Safe Harbor Statement
This release contains "forward-looking-statements" within the meaning of The Private Securities Litigation Reform Act of 1995, including statements regarding the association between abnormally low testosterone levels and cardiovascular disease in Type 2 diabetes patients, the future studies that the Company may undertake and the findings thereof, and the timing for the commencement of various clinical trials for Auxilium's product candidates during 2006, if at all, and products in development for pain, urology and sexual health. All statements other than statements of historical facts contained in this release, including but not limited to, statements regarding future expectations, plans and prospects for the Company, statements regarding forward-looking financial information and other statements containing the words "believe," "may," "could," "will," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," and similar expressions, as they relate to the Company, constitute forward-looking statements. Actual results may differ materially from those reflected in these forward-looking statements due to various factors, including general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries and those discussed in the Company's Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2006 under the heading "Risk Factors", which is on file with the Securities and Exchange Commission (the "SEC") and may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov or by means of the Company's home page on the Internet at http://www.auxilium.com under the heading "Investor Relations - SEC Filings." There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements.
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Auxilium Pharmaceuticals, Inc.CONTACT: James E. Fickenscher, CFO of Auxilium Pharmaceuticals, Inc.,+1-484-321-5900, jfickenscher@auxilium.com; or Denise Ford of PorterNovelli Life Sciences for Auxilium Pharmaceuticals, Inc., +1-212-601-8308,dford@pnlifesciences.com; or Gregory Gin of Lazar Partners, Ltd. forAuxilium Pharmaceuticals, Inc., +1-212-867-1762, ggin@lazarpartners.com
Web site: http://www.auxilium.com/